Performance of a new hepatitis C assay on the Bayer ADVIA Centaur Immunoassay System

Bayer HealthCare LLC, Diagnostics Division has developed a new third-generation assay for the detection of antibodies to hepatitis C (anti-HCV) in human serum and plasma on the ADVIA Centaur immunoassay system. This assay employs magnetic particle separation technology with direct chemiluminescence for optimal assay performance. The assay is fully automated, requires a sample volume of 10 microl and has a throughput of up to 120 tests per hour. The ADVIA Centaur HCV2 Assay was tested with samples from HCV-infected individuals, blood donors, and hospitalized patients in an extensive performance evaluation at two sites in Europe in order to generate performance data in support of obtaining the Communautés Européennes (CE) mark for European market distribution. The HCV performance evaluation resulted in an overall diagnostic specificity of 99.9% and a diagnostic sensitivity of 100%. Assay performance evaluation, using HCV seroconversion performance panels, resulted in comparable or better results when compared to the comparison assay (Abbott AxSYM3 HCV Version 3.0 Assay). Data from the performance evaluation demonstrate that the ADVIA Centaur HCV Assay is a specific and sensitive automated immunoassay for detection of antibodies to hepatitis C virus with performance that is comparable to that of currently marketed assays. Additionally, this assay has the advantage of being on the ADVIA Centaur immunoassay system, which provides the flexibility of high throughput and full automation.